1. Field of the Invention
The present invention relates generally to a method of identifying a subject having an increased risk of developing cervical cancer based on levels of IGF-II in serum and levels of EGF-R and HPV-E6/E7 in cervical epithelial cells and in serum.
2. Background Art
Annual pap smear screening in the USA results in 10 to 15% abnormal cytopathology. For low grade cervical epithelial neoplasia (CIN), the need for treatment in all cases is not clear. The ability to identify patients with CIN who are at greater risk for progression to invasive cancer may allow for more selective treatment protocols, and reduce the number of unnecessary treatments.
Although cytological screening and treatment protocols have already reduced cervical cancer deaths, cervical cancer is still the leading cause of death for women in third world countries. It remains the leading gynecological malignancy in this country with 14,500 new cases and 4,800 deaths every year. (Parker S L, et al, CA Cancer J. Clin. 1997;47:1-27.) About 25% of women with histologically proven high-grade intraepithelial neoplasia are not identified to be at risk during routine gynecological examination. (Blomfield, P I, et al. CBJBrit J Obstet Gyn 1998; 105:486-492; Genest D R, et al.; Arch Pathol Lab Med 1998; 122:338-341.) Although surgical therapy is successful most of the time, metastasis into other locations is hard to diagnose until the cancer is well advanced. This is because the imaging techniques utilized in conjunction with clinical staging fail to reliably identify occult lymphatic spread. (Kim, P Y et al., Gyn Onc 69:243-247; 1998.) The ability to assess patients at risk for metastasis of an invasive cancer would allow the implementation of more appropriate treatment protocols with possible reduction of morbidity and mortality.
The importance of identifying those women with CIN who are at risk for progression into cervical cancer cannot be overemphasized. A rapid cervical tissue or blood test that may help identify those women with CIN who are at risk for developing cervical cancer and help monitor the therapy efficacy will be valuable diagnostic tools. Similarly, a blood test that could identify cervical cancer patients whose cancer was undergoing metastasis.